Solid Biosciences Inc. SLDB announced that the FDA has cleared its investigational new drug (IND) application to begin clinical studies on its novel AAV-based gene therapy candidate, SGT-212, for the ...

Plans for filing an IND was agreed with the FDA in a recent meeting –– Positive preclinical results of the small-diameter ATEV were recently ...

The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small cell lung cancer and other solid tumor indications.

Humacyte (HUMA) announced that it plans to file an Investigational New Drug, IND, application with the U.S. Food and Drug Administration, FDA, ...

Solid Biosciences (SLDB) announced that the FDA has cleared its investigational new drug, or IND, application for SGT-212 for the treatment of Friedreich’s ataxia, a degenerative disease caused ...

IPH4502 is a novel and differentiated topoisomerase I inhibitor ADC designed to precisely target Nectin-4, a cell adhesion ...

The FDA has approved the investigational new drug application of 225Ac-SSO110, allowing for the start of a phase 1/2 trial in ...

cleared its Investigational New Drug (IND) application for TYRA-300 allowing the company to proceed with a Phase 2 clinical trial of TYRA-300 in low-grade, intermediate risk non-muscle invasive ...

The FDA approved the phase 2 Explore-OSA trial set to assess the highly selective aldosterone synthase inhibitor, ...

INCHEON, South Korea, Jan. 15, 2025 /PRNewswire/ -- Celltrion, Inc. (068270.KS), a leading global biopharmaceutical company, today announced its innovative drug development strategy in the rigorous ...

The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...

VisiRose Inc. (”VisiRose” or the “Company”), a privately-held, clinical-stage biotechnology company developing novel ocular ...